FDA (Devices) recall action 92760
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.